Daniel Wallace, MD: Comparable Infection Rates Observed in Patients Receiving Belimumab, Placebo


Patients with systemic lupus erythematosus exhibited comparable or higher incidence rates of infection in the placebo cohort compared with belimumab.

Daniel Wallace, MD: Comparable Infection Rates in Patients Receiving Belimumab, Placebo

Daniel Wallace, MD

Credit: Cedars-Sinai

In an interview with HCPLive, Daniel Wallace, MD, associate director of the Rheumatology Fellowship Program at Cedars-Sinai Medical Center and clinical professor of medicine at the David Geffen School of Medicine at UCLA, discusses his study “Cumulative Infections by Week 52 Among Patients with SLE: A Summary of Data from Placebo-Controlled Belimumab Studies,” which will be presented at the annual American College of Rheumatology (ACR) Convergence 2023.1

Results indicated over a 52-week period, infections of special interest and serious infections were observed at a comparable or higher incidence in patients treated with placebo compared with belimumab.

In the phase 4 Belimumab Assessment of Safety in Systemic Lupus Erythematosus (BASE) study, infection data were sourced, and pooled safety data were assessed. Patients received belimumab 10 mg/kg/month intravenously, an approved treatment for systemic lupus erythematosus (SLE) and lupus nephritis (LN), or placebo, plus standard therapy for 48 weeks. The number of serious infections and infections of special interest, including opportunistic infections, active tuberculosis, sepsis, and herpes zoster, were summarized.

Patients with SLE have a high risk of developing infections, leading to a cause of mortality in this patient population. Serious adverse events of infection and infestation occurred slightly more frequently in patients treated with placebo when compared with belimumab. Similar interest rates were of a higher or comparable interest in BEL116559 compared with BASE and occurred more frequently in placebo in both datasets.

Why is it important to evaluate the incidence of infections in this patient population?

Infections are a major concern giving anybody biologic therapy and it's a reason why many doctors don't give patients biologic therapies if they're diabetic or if they're on steroids, but this study turns the results on its head because it's actually safer.

What were the key findings of your study?

The key finding of the study is that in over 3000 patients there were fewer infections in patients given the biologic than those who were not. That may have something to do with the concurrent medications or immunosuppressants that patients were on. It's a very encouraging study.

In your opinion, what is the clinical significance of these results?

The clinical significance of this result is that for belimumab, in particular, we don't really have to be that concerned about infectious complications.

Does your team plan on doing any further research on this topic?

This was a retrospective post hoc analysis of about 11 international studies that have been done, most of which were double blind and placebo controlled. We do not plan on doing any further study.

Is there anything else that you'd like our audience to know?

Belimumab is a drug that does not kill cells. It's not like rituximab, for example, it modulates cells. Maybe the fact that it does not kill cells is part of the reason for these results.

What is the biggest news in rheumatology from the past year?

The transition towards looking for T cells more so than B cells and looking for examining interferon and its role in the immune system.


  1. Sheikh S, Withrop K, Yazdany J, Navarra S, et al. Cumulative Infections by Week 52 Among Patients with SLE: A Summary of Data from Placebo-Controlled Belimumab Studies. Presented at: American College of Rheumatology Convergence. San Diego, CA. November 10 – 15, 2023.
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